Vonoprazan-based triple and dual therapy versus bismuth-based quadruple therapy for Helicobacter pylori infection in China: a three-arm, randomised clinical trial protocol.

BACKGROUND: Helicobacter pylori infection and associated diseases are a growing global public health issue. H. pylori infection is the major cause of gastric cancer, over 90% of duodenal ulcers, and over 70% of gastric ulcers. The infection rate of H. pylori is approximately 50%, and approximately 50% of new cases of gastric cancer worldwide occur in China. Bismuth (BI)-based quadruple therapy is recommended as the first-line treatment for H. pylori in China. Vonoprazan (VPZ), a new potassium-competitive acid blocker that can inhibit gastric acid secretion more effectively than proton pump inhibitors (PPIs), has been combined with antibiotics to effectively eradicate H. pylori. In this study, we compared the efficacy and safety of two VPZ-based therapies with that of BI-based therapy for H. pylori treatment. METHODS: A three-armed randomised controlled trial (RCT) is being conducted in Shenzhen, with 327 participants recruited from the Gastroenterology Clinic of the University of Hong Kong-Shenzhen Hospital. Patients were diagnosed with H. pylori infection based on a positive 13C-urea breath test (UBT). Patients are kept naïve to their treatment and are randomly assigned in a 1:1:1 ratio to either VPZ-based triple, VPZ-based dual, or BI-based quadruple therapy for 14 days. All groups are subjected to follow-up evaluations of safety, adverse drug reactions, and clinical variables in the first, second, and fourth weeks after treatment. Successful eradication is confirmed by a negative 13C-UBT six weeks after treatment. If initial treatment fails, (1) those patients are turned to another regimen, or (2) a drug resistance test is conducted, after which an individualised treatment regimen shall be prescribed according to antimicrobial susceptibility testing. The resulting data will be evaluated using intention-treat and a per-protocol analysis. DISCUSSION: This study is the a RCT aims to evaluate the efficacy and safety of 14-day VPZ-based triple and dual therapies in comparison with BI-based quadruple therapy. The outcomes of this study may allow treatment recommendations and update drug instructions in China. TRIAL REGISTRATION: Chinese Clinical Trial Registry (No. ChiCTR2200056375). Registered on February 4, 2022, https://www.chictr.org.cn/showproj.aspx?proj=141314.

Thiopurines prevented surgical recurrence in patients with Crohn's disease after intestinal resection: Strategy based on risk stratification.

BACKGROUND AND AIM: Thiopurines (TPs) are effective in reducing clinical and endoscopic recurrence in postoperative patients with Crohn's disease (CD). However, whether TPs could prevent surgical recurrence (SR) remains unknown. We aimed to explore whether TPs could prevent SR and identify risk factors associated with SR. METHODS: This was a retrospective cohort study of 246 postoperative patients with CD. Cox proportional hazard model was used to identify risk factors for SR. Patients were stratified according to the presence of risk factors. RESULTS: A total of 50 (20.3%) patients suffered SR after a mean follow up of 54.3±46.4 months. Multivariable analysis showed independent risk factors for SR were penetrating disease behavior (HR 8.628; 95% CI 1.573-47.341; P = 0.01), ileocolonic disease location (HR 2.597; 95% CI 1.047-6.445; P = 0.04) and isolated upper gastrointestinal disease (UGID) location (HR 5.082; 95% CI 1.496-17.267; P = 0.009). However, use of TPs after surgery significantly reduced the risk of SR (HR 0.120; 95% CI 0.063-0.231; P < 0.001). When stratifying patients according to risk factors, there was no statistical difference of SR between patients treated or not by TPs (P = 0.08) in low-risk group (n = 46). However, in high risk group (n = 200), patients with TPs use had a lower risk of SR than those without TPs (HR 0.093; 95% CI 0.048-0.178; P < 0.001). CONCLUSIONS: Penetrating disease behavior and ileocolonic/isolated (UGID) location were associated with SR in CD patients. TPs use was beneficial in decreasing risk for SR in CD patients at high risk.

Isolated Rectal Tuberculosis Diagnosed with Empirical Anti-tuberculous Therapy.

Isolated rectal tuberculosis (TB) is a rare condition, even in those parts of the world, where pulmonary TB is common. Herein, we report a case of 29-year female patient with isolated rectal TB, who presented with features of abdominal pain and bloody purulent stool. She was diagnosed by empirical anti-TB treatment due to lack of specific imaging, endoscopic, immunological, histopathological and etiological findings.

Over-reaching beyond disease activity: the influence of anxiety and medical economic burden on health-related quality of life in patients with inflammatory bowel disease.

PURPOSE: Many patients with inflammatory bowel disease (IBD) have impaired health-related quality of life (HRQOL). The influence of psychological and economic factors on HRQOL has not been fully elucidated in IBD. Therefore, we aimed to identify the predictors of HRQOL in an IBD cohort. PATIENTS AND METHODS: This was a cross-sectional cohort study of patients presenting to our tertiary IBD center. HRQOL was measured using the 36-item Short Form Health Survey (SF-36) and the Inflammatory Bowel Disease Questionnaire (IBDQ). Anxiety and depression were assessed by the Hospital Anxiety and Depression Scale (HADS). Perceived stress and perceived social support were also assessed by standardized scales. Demographic, socioeconomic and clinical data were obtained from a prespecified questionnaire and patients' medical records. Univariate analyses and multiple regression analysis were performed to identify predictors of HRQOL. RESULTS: A total of 242 IBD patients were recruited, and the questionnaire return rate was 90.5% (219/242). The prevalence rates of anxiety and depression were 24.7% and 17.4%, respectively. In all, 30.6% of the patients spent over half of their income to cover medical costs. Multivariate analysis revealed that anxiety symptoms (P<0.001), active disease (P<0.001) and higher medical expenditures (P=0.001) were strong and independent predictors of reduced HRQOL. CONCLUSION: Psychological factors and costs of medical care strongly impair HRQOL in IBD, independent of the disease activity. Psychological counseling and socioeconomic support programs should be considered for integration into the management of IBD patients.